NCT03806933.

Methods	Randomised, double‐blind, multicentre study to investigate the safety and duration of effect of different NT 201 Dose groups following the treatment of glabellar frown lines, phase II trial
Participants	240 participants, older than 18 years old, both genders. Inclusion criteria Moderate (score = 2) to severe (score =3) GFL at maximum frown as assessed by investigator on the 4‐point FWS Moderate (score = 2) to severe (score =3) GFL at maximum frown as assessed byparticipant on the 4‐point FWS Exclusion criteria Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection Previous treatment with any facial cosmetic procedure (e.g. chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment tattooing of eyebrows) in the glabellar area within the last 12 months before injection Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face Any surgery or scars in the glabellar area Marked facial asymmetry Eyelid ptosis Marked brow ptosis and/or dermatochalasis Ongoing severe or unstable medical conditions, e.g., systemic infection, or pulmonary disease, at the discretion of the investigator Countries: USA and Germany
Interventions	Intervention ‐dose‐rangingIncobotulinumtoxinA, intramuscular injection into the glabellar area Open‐label extension
Outcomes	Primary outcome Duration of effect as defined by time between treatment and relapse to baseline status [ Time Frame: From time of treatment to up to 360 days ] Secondary outcomes Duration of effect whereby effect is defined by a score of none (0) or mild (1) at maximum frown as assessed by the investigator according to FWS [ Time Frame: From time of treatment to up to 360 days ] Duration of effect whereby effect is defined as 2‐point improvement from baseline at maximum frown as assessed by the investigator according to FWS [ Time Frame: From time of treatment to up to 360 days ] Percentage of subjects rated as none (0) or mild (1) at maximum frown by investigator's rating on FWS at Day 180 [ Time Frame: Day 180 ] Percentage of subjects rated as none (0) or mild (1) at maximum frown by subject's rating on FWS at Day 180 [ Time Frame: Day 180 ] Percentage of subjects rated as at least 1‐point improvement compared to baseline at maximum frown by investigator's rating on FWS at Day 180 [ Time Frame: Day 180 ] Percentage of subjects rated as at least 1‐point improvement compared to baseline at maximum frown by subject's rating on FWS Subject at Day 180 [ Time Frame: Day 180 ]
Notes	Supported by Merz Pharmaceuticals GmbH